Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Procedure: open flap debridement; Biological: Nano-crystalline hydroxyapatite silica gel

• Registration Number: NCT02507596
• Lead Sponsor: Cairo University

Brief Summary

A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.

Detailed Description

Thirty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched two- or three-walled intrabony defects. Patients were equally assigned into the experimental group; Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6 months postoperatively.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Primary Completion: 2019-10
• Study Completion: 2019-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Severe chronic periodontitis patients.
• having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.

Exclusion Criteria

• Pregnant women
• Subjects had <22 permanent teeth
• Having any given systemic disease
• Taking any type of medication and/or antibiotic therapy during the 3 months before the study
• Received periodontal treatment within the past 12 months Current or former smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open flap debridement	open flap debridement	an open periodontal flap without adding bone graft.
Nano-crystalline hydroxyapatite silica gel	Nano-crystalline hydroxyapatite silica gel	hydroxyapaptite bone graft with nano particle size in silica gel will be used to fill in the defect after opening a periodontal flap

Primary Outcome Measures

Name	Time	Method
Clinical attachment level	change from Baseline at 6 months	Change from baseline in clinical attachment level in mm in chronic periodontitis patients at 6 month

Secondary Outcome Measures

Name	Time	Method
bone defect area	Baseline and 6 months	Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month
pocket depth	Baseline and 6 months	Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine, Cairo University; 🇪🇬 Cairo, Egypt